Nasal support device for domestic mammals and method

ABSTRACT

The present disclosure provides a device and method for facilitating air flow in the nasal passage of a domestic animal. The nasal support device (NSD) disclosed herein is useful for facilitating air flow during rest, physical exertion, respiratory ailment, etc. The NSD secures to the nose of a domestic animal to support the unsupported lateral vestibular walls of the nasal passages by lifting or stenting.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a continuation-in-part of copending U.S. Ser.No. 08/843,741 filed Apr. 21, 1997, the entire disclosure of which isincorporated by reference herein.

FIELD OF THE INVENTION

The present invention is directed to facilitating air flow through thenasal passages of a domestic animal. Specifically, the inventionprovides a device and method for supporting the soft tissue structuresof the nasal passages of a domestic animal.

BACKGROUND OF THE INVENTION

Portions of the following discussion of the nasal anatomy of domesticmammals are excerpted from R. Nickel et al., The Viscera of DomesticAnimals, (2nd revised ed.), Springer-Verlag, New York. Hiedelberg,Berlin (1979), pp. 211-221. This is an excellent text on the comparativevisceral anatomy of domestic mammals. As used herein, the terms “mammal”and “animal” are used synonomously and refer to non-human mammals.

The nasal anatomy of domestic animals is considerably different thanthat of a human. Unlike the human nose that projects distinctly from theface, in domestic animals, the nose is incorporated into the face andforms the large dorsal and lateral areas rostral to the eves. Thenostrils in the apex of the nose are the entry to the respiratory systemof domestic mammals. Once passing through the nostrils, inspired airmoves into the nasal cavities and continues through the nasopharynx,larynx, trachea and lungs.

At the apical entrance to the nose the nostrils are partitioned by thenasal septum to divide the nasal cavity into right and left halves. Thecaudal portion of the septum is bony, while rostrally the septumconsists of cartilage which becomes progressively more flexible towardthe apex.

The wall of the nose consists of skin externally and a middle supportinglayer of bone caudally and cartilage rostrally. The nasal cavity islined by a mucous membrane. The rostral bones forming the wall of thenose include the nasal, maxillary and incisive bones. The free bordersof the nasal and incisive bone provide attachment for the cartilageswhich support the nostrils. The supporting bones and cartilages of thenose are associated with the nasal muscles that regulate the size of thenostrils.

The dorsal and ventral lateral nasal cartilages are formed by thewidening of the rostral part of the nasal septum along its dorsal andventral margins. In the horse, the ventral lateral nasal cartilage issmall and may be absent. In many domestic animals, there is no lateralsupport for the soft tissue over the rostral nasal passage caudal to thenostril.

A further difference in the formation of the nasal cartilages of thehorse is the presence of alar cartilages. The alar cartilages consist ofa ventral cornu and a dorsal lamina and support the nostrils dorsally,medially and ventrally. The lamina of the alar cartilage and the medialaccessory cartilage support the nasal diverticulum, a blind pouch in thedorsal aspect of the nostril.

The muscles of the nose and upper lip act to dilate the nostrils. Thisis particularly noticeable during labored breathing. In the horse, thesemuscles are well developed and can transform the normally semilunarnostrils to become circular.

The dorsal lateral area of the rostral nasal cavity that is caudal tothe alar cartilages in the nostrils of the horse includes a region ofunsupported soft tissue which can be drawn into the nasal cavity duringinspiration of air into the nasal passages. The nasal diverticulum ofthe horse is a part of the soft tissue structures of the horse which canbe drawn into the nasal cavity. When the soft tissue is drawn in, it cannarrow the nasal cavity and reduce the area for the intake of air, thusreducing the air movement into the nasal passages and ultimately to thelungs where the oxygen is transferred in the pulmonary aveoli. Thephysiological effects of reduced oxygen transfer at rest and duringphysical exertion are documented. Some experts have theorized thatexercise induced pulumonary hemorrhage (EIPH) in performance horses iscaused by asphyxia due to abnormal resistance of a closed or partiallyclosed upper airway. The upper airway being defined as the region of therespiratory tract lying between the nostrils and the windpipe at thelevel of the first rib. Hence, the nasal passages are part of thisregion. Dr. Robert Cook. “EIPH or AIPE? A Tufts University Researchersuagests that bleeding is not caused by EIPH, but by asphyxia”, TheEquine Athlete. p. 22-23 (March/April 1997).

Devices for dilating the outer wall tissue of the nasal passages inhumans have been described in, for example, U.S. Pat. Nos. 5,533,503;5,546,929; 5.553,605; and RE 35.408. These devices, however, do notaddress the unique soft tissue structures and mechanical problemsassociated with providing support for the nasal tissues of non-humanmammals, especially large performance mammals such as the horse andcamel.

Accordingly, there is a need to reduce the detrimental effects ofreduced air intake, or to enhance the physiological benefit of increasedair intake, during physical exertion of domestic mammals. Specifically,there is a need to increase, or reduce the decrease of, nasal passagenarrowing that can occur during breathing in domestic mammals,especially performance animals such as the horse, camel, and dog.

SUMMARY OF THE INVENTION

The present invention provides a device and method for using the deviceto support the unsupported nasal tissues of a domestic animal. Theinvention addresses providing support in view of the structural andphysiological characteristics unique to the nose of a non-human animal,for example, a horse. In some embodiments, a nasal support device (NSD)disclosed herein can reduce inspiratory air flow impedance by at leastabout 5-10%

In one embodiment the invention is a NSD for securing to the nose of adomestic animal. The NSD provides support to the right and left lateralvestibular walls of a domestic animal. The device includes a supportlayer and a right and left side piece which when secured to the nose ofthe animal are positioned to provide structural support to the right andleft lateral vestibular walls. The side pieces of the device can meet atthe midline region of the device. When secured to the nose of a domesticanimal, the midline region of and NSD of the invention straddles theleft and right nasal bones of the animal. The sides and the midlineregion each have a rostral end, a caudal end and a rostral-polldimension. In one embodiment, the rostral-poll dimension of the midlineregion is at least as great as either of the rostral-poll dimensions ofthe side pieces. In an alternative embodiment, the rostral-polldimension of the midline region is greater than either of therostral-poll dimensions of the side pieces. In some embodiments, therostral end of the NSD can extend rostrally between the nostrils in theform of a “tongue” to provide externalizing support to the soft tissuesbetween the nostrils.

An NSD configured according the invention can be used on many differentanimals. In one embodiment an NSD is sized to fit a member of theEquidae family, including the domestic horse. The device is suitable foradults and young animals. In general, the structural aspects aspects ofan NSD of the invention can be configured and sized to fit the nose of,for example, a dog, human, horse, camel, etc.

In general, an NSD comprises a support layer, an engaging layer, and insome embodiments a surface layer and/or pad layer. The support layer ofan NSD can include one or more lift members to support the vestibularwall. The lift members can traverse the nose and extend to a pointdorsal to the ventral border of the vestibular wall, or beyond theventral border of the vestibular wall lateral to the incisive bone.Alternatively, one or more lift members of an NSD can be applied overeach vestibular wall and stent each vestibular wall independentlywithout connecting to one another across the midline of the nose.

The invention further provides a method for supporting a first andsecond vestibular free wall of a domestic animal by securing a devicewhich supports the first and second vestibular free walls to the nose ofthe animal. In one embodiment, the method includes use of an NSD asdisclosed herein.

The method of the invention provides for facilitating air flow throughthe nasal passages of a domestic animal. The device and method of theinvention are particularly advantageous for use in the horse and arebeneficial for facilitating athletic performance or for reducing theoccurrence, severity or affect(s) of respiratory diseases in an adult oryoung animal.

A device and method according to the invention can be used on an animalthat is running freely in a pasture, or wearing saddlery, harnesses orother equipment that can be attached to the nose of the animal.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 a is a top view of one configuration of an embodiment of an NSDwhich incorporates the functional aspects of the invention.

FIG. 1 b is a top view of a second configuration of an embodiment of anNSD which incorporates the functional aspects of the invention.

FIG. 1 c is a top view of a third configuration of an embodiment of anNSD which incorporates the functional aspects of the invention.

FIG. 1 d is a top view of a fourth configuration of an embodiment of anNSD which incorporates the functional aspects of the invention.

FIG. 1 e is a top view of a fifth configuration of an embodiment of anNSD which incorporates the functional aspects of the invention.

FIG. 1 f is a top view of a sixth configuration of an embodiment of anNSD which incorporates the functional aspects of the invention.

FIG. 1 g is a top view of a seventh configuration of an embodiment of anNSD which incorporates the functional aspects of the invention.

FIG. 1 h is a top view of an eighth configuration of an embodiment of anNSD which incorporates the functional aspects of the invention.

FIG. 1 i is a top view of a ninth configuration of an embodiment of anNSD which incorporates the functional aspects of the invention.

FIG. 2 is a perspective view of the bony and cartilaginous anatomy ofthe rostrum nasal cavity of the horse.

FIG. 3 is a profile view of the bony anatomy of the rostral nasal cavityof the horse.

FIG. 4 is a dorsal or top view of the bony anatomy of the rostral nasalcavity of the horse.

FIG. 5 is a top plan view of one embodiment of an NSD with the surfacelayer removed and the support layer exposed.

FIG. 6 is a top plan view of a second embodiment of an NSD with thesurface layer removed and the support layer exposed.

FIG. 7 is a top plan view of a third embodiment of an NSD with thesurface layer removed and the support layer exposed.

FIG. 8 is a frontal view of a horse having an embodiment of an NSD ofFIG. 5 or 6 secured to its nose.

FIG. 9 is a front view of a horse having an embodiment of an NSD of FIG.7 secured to its nose.

FIG. 10 is an exploded perspective view of the components of theembodiment of an NSD configured as shown in FIG. 5.

FIG. 11 is a bottom plan view of an engaging layer of an embodiment ofan NSD having a discontinuous adhesive pattern.

FIG. 12 is a bottom plan view of an embodiment of an NSD having holesthroughout the thickness of the device.

FIG. 13 is an exploded perspective view of the NSD shown in FIG. 12.

DETAILED DESCRIPTION OF THE INVENTION

The invention is directed to devices and methods for supporting the softtissue at the rostral aspect of the nasal cavity of domestic mammals.Specifically, the devices and methods disclosed herein provide supportfor the unsupported region of the “vestibule” in the rostral nasalcavity.

As used herein, domestic mammals include most non-human production andperformance animals having a nose incorporated into the face, ratherthan projecting therefrom, that can benefit from a device according tothe invention. Such mammals include dogs, sheep, goats, cattle, horses,camels, llamas, etc. A device according to the invention can beparticularly useful for members of the Equidae family including horses,donkeys, mules, zebras etc.

As used herein, “performance activities or work” includes activitiessuch as pulling, driving, racing (flat, steeple, barrel, etc.),eventing, hunting, jumping, rodeoing, trail riding, endurance riding,etc. In general, the device can be used anytime it is desired tofacilitate or enhance nasal air intake. In addition, to facilitating airflow, an NSD according to the invention can also be used to treat orprevent respiratory ailments in adult or young animals such as foals andcalves. It is foreseen that the devices and methods of the invention maybe particularly beneficial in horses for reducing the severity oraffect(s) of laryngeal hemiplegia, chronic obstructive pulmonary disease(COPD) or exercise related pathologies such as myositis, dorsaldisplacement of the soft palate (DDSP), or exercise induced pulmonaryhemorrhage (EIPH) or “bleeding”.

As used herein, the term “rostral” refers to that aspect of the nose oranatomical structure closest to the apex of the nose. “Caudal” refers tothat aspect of the nose closest to the poll or caudal aspect of the headrelative to the apex. The “vestibule” refers to the rostral aspect ofthe nasal cavity that is defined by the alar cartilages rostrally, theincisive bone ventrally, the nasal bone dorsally, the caudalintersection of the incisive and nasal bones caudally, and the nasalseptum medially. Thus, supported regions of the vestibule are supportedby bone or cartilage.

The “unsupported” region of the vestibule is also referred to as the“lateral (free) wall” of the vestibule or “vestibular wall”. The lateralwall of the vestibule includes the unsupported soft tissue defined bythe nostrils rostrally, the lateral free border of the nasal bonedorsally, the dorsal free border of the incisive bone ventrally, and theintersection of the nasal and incisive bone caudally. In the horse, thedorsal border of the unsupported region can include the dorsal lateralnasal cartilage and, in some species, the ventral border can include theventral lateral nasal cartilage. Herein, “soft tissue” has its generalmeaning including skin, muscle, fat, connective tissue or associatedintegumentary structures.

In general, the anatomy of soft muzzled mammals such as the horse andcamel give rise to unique physical mechanical problems in supporting thevestibular soft tissues. For example, in the horse, the alar cartilagesthat are attached at the rostral border of the nasal septum supports thealar fold which gives rise to the blind cutaneous pouch referred to asthe “false” nostril. Providing structural support for the vestibule ofthe horse preferably includes providing support of the alar fold. Asuitable support device according to the invention, preferably causesminimal irritation to the skin or other anatomic structures of theanimal when in use or after removal.

Other anatomical and physiological characteristics of a soft muzzleanimal must be overcome to provide a suitable NSD for these animals. Forexample, the hair that covers the external vestibular tissues can reducethe ability of an NSD to remain adhered to the animal's nose undercertain conditions. In addition, the presence of numerous sweat glandsin this region, with or without the presence of hair, can alsosignificantly reduce the ability of an NSD to remain adhered to thisregion when the animal is perspiring.

A further unique characteristic is the significant mobility of theexternal soft tissues in the vestibular region of some animals. Forexample, the muscular anatomy associated with the vestibular wall andnostrils of the horse enables considerable flexion, extension, twistingand side-to-side motion of the external vestibular tissues. The repeatedin and out movement of the vestibular tissues during inspiration andexpiration also affects the ability of an NSD to maintain a functionalposition in these animals. Thus, the combination of hair, sweat andvestibular wall movement during intense exercise present uniquechallenges to adherence and functioning of an NSD in certain animals,such as the horse.

Another factor considered in providing an NSD for support of thevestibule of a horse or camel is the equipment, including saddlery orharnesses, worn by the animal hen working. Generally, “saddlery” refersto bits, bridles, martingales, muzzles, headcollars, saddles and otherequipment used with a riding animal. “Harness” refers to equipment usedwith a driving animal. A suitable configuration and arrangement of anNSD of the invention preferably does not interfere with the functioningof saddlery or harnessses and the saddlery or harnesses preferably donot interfere with the functioning of the NSD.

It should be noted that an NSD according to the present invention needonly engage the lateral free wall of the vestibule, it does not need toengage the nostrils. Upon visual inspection it will be appreciated thatthe nostril of the horse can expand to a cross-sectional area that isgreater than an unsupported cross-sectional area measured in the nasalcavity in the region of the lateral vestibular wall. However, it isforeseen that support of the nostril could be provided in somecircumstances. In the horse, for example, the muscles of the nose andupper lip generally provide significant flaring of the nostril duringlabored breathing.

Some exemplary embodiments of a device of the invention and itscomponents are described below. Throughout the specification guidance isprovided by examples of representative groups, the groups are not meantto be limiting.

The configuration and arrangement of an NSD of the invention isdetermined by the configuration of the tissue to be supported, theamount of support needed and the unique physiological or anatomicalcharacteristics of the animal. Generally, the unique nasal anatomy ofdomestic animals necessitates configurations, arrangements or dimensionswhich are different than that required for a human nose. In addition, asdiscussed previously, hair, sweat and vestibular wall mobility affectthe structural arrangement necessary for functionality of an NSD.

In a typical embodiment, a herein disclosed NSD provides support to theright and left lateral vestibular walls of the animal. Generally, thedevice includes a support layer having a right and left side piece whichwhen secured to the nose of the animal are positioned to providestructural support to the right and left lateral vestibular walls. The“right” and “left” side pieces can also be referred to as “first” and“second” or “second” and “first” side pieces. The NSD is generallybilaterally symmetrical and does not utilize a narrow intermediatesection between the side pieces. The side pieces of the device meet atabout the midline a midline region of the device. When the NSD issecured to the nose of a domestic animal, the intersection of the rightand left side pieces at the midline region substantially straddles theleft and right nasal bones of the animal.

The side pieces and the midline region of an NSD each have a rostralend, a caudal end and a rostral-poll dimension. Because of the size andrelated anatomy of the surface area of the vestibular free wall of, forexample a horse, to provide sufficient support to benefit the animal,the rostral-poll dimension at the midline region of an NSD of theinvention can be substantially equal to or greater than the rostral polldimension of the side pieces that engage the vestibular free wall.Hence, in one embodiment, the rostral-poll dimension of the midlineregion is at least as great as the rostral-poll dimension of either ofthe side pieces. In an alternative embodiment, the rostral-polldimension of the midline region is greater than the rostral-polldimension of the right or left side piece. However, a device having arelatively narrow intermediate region similar to some devices availablefor humans, and modified to include an increased surface area, modifiedsupport system and modified adhesive system may provide some benefit toan animal.

In addition, it is foreseen, that although the preferred configurationof an NSD of the invention is particularly advantageous for use onanimals such as horses, the unique configurations disclosed herein canprovide an advantageous improvement in dilators for a human nose.Moreover, a device having the general configuration of a preferredembodiment of the invention, but sized for use with a human nose, canalso advantageously provide a sun blocking, or visor effect, for theproximal and/or rostral end of a human nose. Two configurationalembodiments particularly suited for a human or animal nose areillustrated in FIG. 1 h and 1 i. In one preferred embodiment for humans,at least two lift members of 1400A Gauge MYLAR®, available from DuPontFilms, Wilmington Del, are applied transversely as support members in anNSD configuration such as that illustrated in FIG. 1 h.

In some embodiments, the rostral end of the NSD at or near the midlineregion extends to the apex of the muzzle between the nostrils and isreferred to as a “tongue”. This embodiment can provide lift support tothe most rostral aspect of the soft tissues and cartilaginous nasalseptum between the nostrils.

The structural configuration and arrangement of an NSD can vary in someaspect(s) and still maintain the mechanical functioning of a deviceaccording to the invention. Personalization of the external design of anNSD can reflect aesthetics, personal tastes, racing colors, etc. Theoverall appearance of the embodiments illustrated in the presentdisclosure are not exhaustive of those which are within the scope of theinvention. Examples of a few general configurations which impart some orall of the functional aspects of the invention are shown in the top planviews of FIG. 1 a-i, and 5-13. Generally the bottom plan configurationof an NSD is substantially identical to the top plan configurationshown. The side plan view is substantially void of ornamental features.

As used herein, the term “support” refers to reducing the amount ofnarrowing of the nasal passage that can occur during inspiration orexpiration of domestic animals. Accordingly, “support” can include somedrawing in of the vestibular free wall at the rostral nasal passageduring inspiration, but less than that which would occur without adevice of the invention. “Support” also includes maintaining theposition of the external soft tissue over the rostral nasal passage in aneutral position. As used herein, “neutral” to refers to a state wherethe unsupported vestibular tissues are neither drawn into the nasalcavity nor protruding externally relative to a resting position. In somearrangements, “support” also includes maintaining the vestibular freewall in a “distended” outward position relative to the neutral position.

The configuration and arrangement of a support device for animals takesinto account the anatomical and physiological characteristics of thevestibular free wall as well as the bony structures defining itsborders. Moreover, in most large domestic animals, the structuralsupport necessary to support the lateral free wall must also take intoaccount the weight of the tissue supported and the proper leveraging fordistributing the weight supported without causing pressure sores orother irritation to surrounding tissues. In addition, due to the musclecontrol of the upper lip of the horse, supporting the vestibular freewall must also address the active and passive mobility of the muzzlestructures.

The size of a device of the invention can vary. Appropriate sizeddevices will typically correspond with muzzle size which can vary withthe body size, breed, age, and sex, of the animal. It is foreseen thatsmaller size NSDs for young animals, such as calves and foals can bebeneficial in treating, for example, upper respiratory ailments. In someembodiments, the rostral-poll midline dimension of an NSD for an averagesized adult horse is about 3 to 16 cm, preferably 6-14 cm and therostral poll dimension of the right and left side is about 3 to 12 cm.However, larger and smaller sizes may be used.

The transverse dimension of an NSD can also vary. The “transversedimension” is defined as the length of the device from the peripheraledge of one side of the device to the peripheral edge of the second sideof the device. The transverse dimension can be approximately equal atthe rostral and caudal edge. Alternatively, the transverse dimension canvary in a single device depending if measured, for example, along thecaudal edge, the rostral edge, the narrowest part or the widest part. Inone embodiment of an NSD for an average size horse, the transversedimension at the narrowest part can be about 5-12 cm and about 10-17 cmat the widest part.

Typically, an NSD according to the invention includes at least a“support layer” and an “engaging layer”. In some embodiments a “surfacelayer” can be present to cover the side of the support layer that isaway from the nose of the animal when the device is secured to the noseof the animal. Some embodiments can also include one or more “padlayers” which can help reduce the chance of pressure sores caused by thedevice.

The support layer provides the majority of the support for thevestibular free wall of the nasal passage of an NSD. Generally supportis provided in the support layer through the use of one or more “liftmembers.” As used herein a “lift member” can be prepared from anysuitable material which provides the desired support to the vestibularfree wall. Examples of suitable materials for a lift member includethermoplastic resins, thermoset resins, shape memory metals, alloys,leather, etc. The lift member can be a unitary open mesh or solidmaterial. Alternatively, the lift member can be two or more individualsections of an open mesh or solid material. A preferred thermoplasticresin for a lift member is a polyester such as MYLAR® available fromDuPont Films, Wilmington Del.

In some embodiments, the lift members are of a generally uniformthickness throughout their length and width. The thickness of the liftmembers will typically be selected based on the support needed, and isgenerally the same throughout. However, the lift member can also vary inthickness in different regions of the device. In addition, a lift memberneed not be the same width throughout its length. That is, the liftmember can be wider at the lateral ends of the lift member.Alternatively, a lift member can be wider in the region that will lieover the midline region of the nose and narrower on the ends.

Suitable thickness for a lift member prepared from a polyester such asMYLAR® for an adult large animal such as a horse is about 0.008 to about0.020 inches. In one preferred embodiment, the thickness of a supportmember for an average size adult horse is about 0.014 inches.

The support layer can include one or more lift members. In oneembodiment using a single lift member, the configuration of theperipheral edge of the lift member can define the external contours ofthe overall device. In other embodiments, two and preferably, three ormore lift members are used. In such embodiments, a plurality of liftmembers can be arranged parallel along the transverse dimension of thedevice. Alternatively, a plurality, of lift members can be orientedperpendicular to one another such that one or more lift members areoriented parallel to the transverse dimension of the device and one ormore lift members are oriented parallel to the rostral-poll dimension ofthe device. In yet another embodiment, two or more lift members can beoriented in a substantially criss-cross arrangement to form an “X”shaped appearance in top plan view.

In some embodiments it is advantageous to provide lift members in arostral caudal direction. Lift members oriented in a rostral caudaldirection can be located in the side pieces to further provide the liftof the NSD. In addition, or alternatively, lift members can be orientedin a rostral caudal direction at or near the midline intersection of thefirst and second side pieces. This arrangement of the lift members isparticularly advantageous for NSD embodiments which extend rostrally toform a “tongue” for support of the soft tissue between the nostrils.

When using multiple solid lift members, the spacing between individuallift members can affect the adherence and overall functioning of an NSD.Appropriate spacing between individual lift members provides for thedevice to adaptively conform to the changing contours of the vestibularwall of an animal during inspiration, expiration or other movements,without disengaging from the animal's nose.

The width, length and spacing of one or more lift members can vary basedon the overall dimensions of the particular NSD. Also, the length of theindividual lift members can vary in a single device so as to traversesome or all of the dorsal-ventral dimension of the vestibular free wall.Preferably, the transverse length dimension of a lift member issufficient to traverse the midline of the animal's nose and extend tothe right and left side pieces beyond the dorsal lateral nasalcartilages to support the right and left vestibular free walls. In someembodiments, the lift members can extend beyond the ventral edge of thevestibular free wall to a point lateral to the incisive bone. Generally,the lift members provide a “lift” effect on the vestibular free wall toreduce drawing of the vestibular free wall into the nasal passage duringrespiration. However, if the lift members extend beyond the ventral edgeof the vestibular free wall to the lateral aspect of the incisive bone,the incisive bone can act with the lift members to “stent” thevestibular free wall and facilitate the reduction of the dawing of thevestibular wall into the nasal cavity that is provided by the liftmembers. This may be particularly advantageous in large animals duringlabored breathing.

When two or more lift members are used, the width of the lift membersand the spacing between lift members are selected for the NSD to providethe desired support to the vestibular wall with sufficient flexibilityto reduce the chance of irriation due to localized pressure atleveraging points on the animal's nose. In addition, use of multiplelift members provides for torsional flexibility of the device whichhelps maintain the functioning of the device when subjected to theunique mobility of an animals vestibular tissues. In one embodiment ofan NSD for an average size adult horse, the length of the lift memberscan be about 4-18 cm, preferably about 9-12 cm, the width can be about0.2 to 2 cm and the spacing between lift members about 0.2 to 2 cm,preferably about 0.3 to 0.7 cm.

In one embodiment, the lift member can be a single member of apreviously described solid or open mesh material that is shaped to stenta single vestibular wall. That is, the outer contours of the lift memberare configured to follow the peripheral margins of the vestibular wall.Preferably, the perimeter edge of the lift member is extended to allowthe lift member to overlap the borders of the vestibular wall by about0.2-2 cm. According to this embodiment, the lift member can include anengaging layer and optionally a surface or pad layer as described below.Preferably, the engaging layer can extend beyond the perimeter of thelift member to enhance adherence to an animal's nose. However, ratherthan connecting at the midline region of the nose, this embodiment of anNSD comprises two separate pieces, that act as a stent for eachvestibular wall.

An NSD preferably includes an engaging layer. The engaging layerprovides for securing an NSD to the animal. If no surface layer(described below) is present and individual lift members are used, theengaging layer can also provide for maintaining the unity of the device.Typically, the engaging layer can secure the NSD to the nose by use ofan adhesive. Other invasive forms of engaging to the nose, such assuturing, are possible but not desired. Preferably, the adhesive isbiocompatible and provides minimal or no contact irritation when appliedto the external tissues of an animal.

Suitable materials for the adhesive of the engaging layer are single ordouble coated medical tape, transfer adhesives, or liquid adhesives. Arelease liner is preferably applied to the NSD to protect the adhesivesurface of the engaging layer until application to an animal. Pressuresensitive adhesives (PSA) can be used. Examples of suitable adhesivesystems are No. 1509 double sided medical tape and No. 9942 HydrocolloidSkin Protective Adhesive available from 3M Co., St. Paul, Minn. Apreferred adhesive system is No. 1524 transfer adhesive available from3M Co., St. Paul, Minn.

The adhesive can be continuous over the surface of the engaging layer.Alternatively, the adhesive can be in a discontinuous pattern that canbe formed in multiple ways. For example, a discontinuous pattern can beapplied as a pre-cut double sided medical tape or transfer adhesive.Alternatively, the adhesive can be applied as a liquid adhesive in adiscontinuous pattern using methods such as gravure coating. A varietyof patterns may be used including circles, ovals stripes or polygons,such as rectangles, squares, triangles etc. The hexagonal patterndepicted in FIG. 11 is conveniently applied, but not required. Thepattern need not be symmetrical. In addition, the discontinuous adhesivepattern may extend to the periphery of the device or a continuouspattern adhesive border can be applied around the perimeter of theengaging layer. In addition, two or more adhesives may be used incombination to optimize adherence under different conditions. Forexample a first adhesive could provide greater adherence under dryconditions and a second adhesive provide greater adherence under moistconditions.

In an alternative embodiment, the adhesive can be applied in acontinuous pattern and subsequently made discontinuous. For example,holes can be formed through the entire thickness of an NSD after acontinuous adhesive is applied to the engaging layer, thus forming adiscontinuous adhesive layer. No particular pattern of holes isnecessary. However, preferably, the pattern of the holes is relativelyevenly distributed over the entire surface area of the device and thelocations of the holes are selected to avoid penetration through thelift members. As discussed above, the shape of the holes forming thediscontinuous pattern can be round, oval, polygons etc. The ratio ofadhesive area:non-adhesive area of a discontinuous adhesive pattern canbe about 90:10 to 10:90, typically about 30:70 to 70:30, and in someembodiments, about 40:60-60:40.

Without being limited to a single theory, it is believed that inaddition to permitting passage of perspiration to the exterior surfaceof the device, the discontinuous adhesive pattern, particularly in theform of holes facilitates malleability of the device to permit thedevice to more readily conform to the surface contours of the vestibularfree wall without loss of adherence or reduced support of the device.

The NSD can include a surface layer. The surface layer is the layerfarthest from the soft tissues of the animal. The side of the surfacelayer closest to the soft tissue of the animal can include an adhesiveto adhere the surface layer to the support layer, to the top side of theengaging layer that may be exposed between lift members, or to the padlayer if used. The surface layer can provide additional support to thevestibular wall and help maintain unity of the components of an NSD. Asuitable surface material can be breathable or non-breathable andtypically includes a biocompatible adhesive. An example of a breathablematerial suitable as a surface layer is No. 1533 available from 3M Inc.,St. Paul, Minn. One preferred non-breathable surface material is No.9906T non-woven medical tape available from 3M Co., St. Paul, Minn. Thismaterial has been found to advantageously flex with the surface contourchanges of the vestibular wall thus reducing the likelihood that thedevice will disengage from the animals nose, for example, duringstrenuous exercise. Preferably, because this material is non-breathable,holes are created through the entire thickness of the device to providefor passage of moisture and further cooperative malleability of the NSD.

The support layer can mount directly to the engaging layer. However, theNSD can also include a “pad layer” applied between the engaging layerand support layer. Alternatively, the pad layer can be applied betweenthe surface layer and the support layer. An adhesive may be applied toboth sides of the pad layer, only a single side or not all. That is thepad layer can be “free floating.”

In another embodiment, a partial pad layer can be applied. According tothis embodiment, the pad layer can be applied between the support layerand the surface layer. The pad layer can be adhered to the layers oneither side of the pad layer or only to the layer on one side. Forexample, the pad layer can be applied between the support layer andengaging layer, but only adhered to the engaging layer and regions ofthe surface layer between individual lift members.

The pad layer can be formed of any suitable known material. Onepreferred material is a polyester material that allows the skin of thevestibular wall beneath the device to breathe. An example of a suitablepad layer is the product SONTARA® (style nos. 8004, 8005, 8027 etc.)available from E.I. DuPont Nemours & Co., DuPont Nonwoven Division, OldHickory, Tenn. SONTARA® is a nonwoven, spunlaced, breathable polyesterfabric.

If no pad layer is used, the support layer can mount directly to theengaging layer using a double sided adhesive. Alternatively, the liftmembers can be adhered to a non-adhesive side of the engaging layer, orto a nonadhesive pad layer using a double sided adhesive such as 3M1509, 3M Inc., St. Paul, Minn. Other arrangements are foreseen. Forexample, the adhesive of the engaging layer can be applied between thesupport layer and surface layer. According to this embodiment, theengaging layer adheres to the animal's nose between individual liftmembers that are not adhered to the animal.

The surface layer can include an ornamental design color, pattern, logoetc. if desired. Alternatively, an ornamental veneer layer can beapplied to the exposed surface of a surface layer or support layer.

The engaging layer, surface layer, or pad layer (if used) can closelyfollow the external contours defined by the support layer.Alternatively, the periphery of the engaging or other layers can extendbeyond the contours defined by the support layer. In a preferredembodiment, extending the periphery of the engaging layer beyond thecontours defined by the support layer can provide improved engagement ofthe NSD to the animal's nose. In one embodiment a margin region of about0.5 cm to 5 cm, preferably about 2-3 cm of engaging layer extends beyondthe support provided by the support layer. If present, the surface layertypically has the same perimeter dimensions as the engaging layer.

Generally, the overall thickness of the device is uniform. Somevariation in thickness can occur due to differences in thickness ofthose regions of the device including the support members and thoseregions having spacing between support members.

The inventors also recognize that single or multiple lift memberswithout a unifying layer (eg. surface layer or engaging layer) can beused. According to this embodiment, an engaging layer, such as apreviously described adhesive, can be applied to the lift member. One ormore lift members can then be applied directly to the animals nose.While this embodiment may address the unique physiological andanatomical aspects of an animals nose as disclosed herein, theapplication and removal of the support members will be cumbersome. Inaddition, the support provided by the surface layer or engaging layer inthe regions between the lift members will be lost.

DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENT

Anatomical reference points and embodiments of an NSD according to theinvention will be described in detail with reference to the drawingsusing the horse as an example. Like reference numerals represent likeparts and assemblies throughout the several views. Reference to thedrawings is not intended to limit the scope of the to invention.

FIG. 1 a-i are each a top view of a configuration of an embodiment of anNSD which incorporates the functional aspects of an NSD as disclosedherein. The embodiments shown are exemplary and are not intended tolimit the scope of configurations that incorporate the principles of theinvention. FIG. 1 c shows various dimensions which can be used tocharacterize an NSD according to the invention wherein letters followedby a subscript “T” are the transverse dimensions including C_(T) is thecaudal edge transverse dimension, R_(T) is the rostral edge transversedimension, N_(T) is the narrowest part transverse dimension and W_(T) isthe widest part transverse dimension. S is the rostral-poll dimension ofthe side piece and M is the rostrum poll dimension of the middlingregion.

Bony anatomical structures which surround the vestibule free wall in thehorse that is supported by a device of the invention is described withreference to FIGS. 2-4. FIG. 2 is a perspective view of the bony andcartilaginous structures of the rostrum nasal cavity of the horse. FIG.3 is a profile view of the bony anatomy and FIG. 4 is a top view of thesame rostrum anatomy of FIG. 3. FIGS. 3 and 4 do not show cartilaginousanatomy of the adult horse.

The lateral free wall of the vestibule is defined dorsal by the dorsallateral nasal cartilage 1 which is the lateral most aspect of the nasalbone 2. The ventral border of the vestibule free wall is defined by thedorsal free wall 3 of the incisive bone 4. The caudal aspect of thevestibule free wall is defined by the intersection 5 of the nasal 2 andincisive 4 bones. The rostrum aspect of the vestibule free wall isbordered by the nostril (not shown) which is supported dorsal by thelamina 6 and ventral by the corn 7 of the allure cartilage 8. The medialaccessory cartilage 9 and the lamina 6 of the allure cartilage supportthe “false” nostril of the horse. The cartilaginous rostrum nasal septum10 is shown in FIG. 2.

FIGS. 5-7 illustrate three different embodiments of an NSD (15, 16, 17)according to the invention. The surface layer is removed in each ofthese figures to expose the top side of the support layer 20 and the topside of the pad layer 21 which covers the engaging layer (not shown).The support layer 20 includes transverse lift members 22 in FIGS. 5-7and longitudinal lift members 23 in FIG. 7. The lift members 22 of FIG.5 are narrower but greater in number than the lift members 22 of FIG. 6.In the embodiment of FIG. 2. the transverse dimension of the liftmembers range from 9 cm to 14 cm, the width of the transverse members isabout 0.6 cm, the spacing between members is about 0.6 cm and thethickness of the lift members is about 0.14 inches; In the embodimentsof FIGS. 5-7, the peripheral contours of the pad layer (and engaginglayer) extend beyond the lift members.

As shown in FIGS. 5-7, an NSD includes a first side piece 24 and asecond side piece 25 that intersect at the midline 26 of the midlineregion 26 a of the device. In use, the rostral end 27 of the device isoriented towards the apex of the nose and the caudal end 28 is orientedtowards the eyes of the animal. In FIG. 5, the midline rostral-polldimension M at the midline 26 is at least equal to the side piecerostral-poll dimension S of side pieces 24 and 25. Also as shown in theembodiments of FIGS. 5-7, preferably, the rostral-poll dimension of theNSD at the midline M is greater than the rostral-poll dimensions S ofthe first or second side pieces 24, 25. In FIG. 7, the NSD includes arostrally extending center piece or “tongue” 29 that can extendrostrally to engage the nose between the nostrils.

In use, an NSD is secured to the animal's nose oriented generally asshown in FIGS. 8 and 9. FIG. 8 is a front view of a horse 30 having anembodiment of an NSD 31 having an external configuration as shown inFIGS. 5 and 6 (15 and 16, respectively) secured to the nose 32. FIG. 9is a front view of a horse 30 having an embodiment of an NSD 17 as shownin FIG. 7 secured to its nose 32. As can be seen in FIG. 9, the tongue29 of the NSD 17 extends between the nostrils 33 of the horse 30.

FIG. 10 is an exploded perspective view of the components making up anembodiment of an NSD 15 as shown in FIG. 5. According to thisembodiment, the engaging layer 40 includes an adhesive surface 41 tosecure the NSD 15 to an animal's nose. A pad layer 42 is adhered to theengaging layer 40. The pad layer 42 can have an adhesive layer or beadhesive free. In the embodiment shown, the engaging layer 40 is adouble sided adhesive such that the top side 43 of the engaging layerwill adhere to the pad layer 42. The support layer 44 includes liftmembers 45. The lift members 45 can be adhered to the pad layer 42using, for example, a double sided adhesive 46. A surface layer 47 canbe applied over the support layer 44 to provide unity, additionalstrength or a “canvas” for applying an ornamental design to the device.Suitable materials for each of the layers have been describedpreviously. The releasable liner for protecting the adhesive surface 41of the engaging layer is not shown.

FIG. 11 illustrates the engaging layer 110 of another embodiment of anNSD 100 with the releasable liner removed. According to this embodiment,a discontinuous adhesive pattern 101 is applied to the NSD 100 as apre-cut medical tape or transfer adhesive or applied as a printed liquidadhesive. As described earlier, a polygon adhesive pattern 104 is one ofseveral suitable discontinuous adhesive patterns. While the illustratedembodiment does not include holes, the areas void of adhesive 102 in theadhesive pattern 101 provide for perspiration to pass through abreathable or non-breathable surface layer to the surface of the NSD. Itis believed that areas void of adhesive 102 of the adhesive pattern 101of the engaging layer 110 facilitates engagement of the NSD 110 to themobile contours of the vestibular wall of some animal's noses, such as ahorse. However, it is also foreseen that a pattern similar to that shownin FIG. 11 can include two different adhesives. That is, a firstadhesive could be applied as the adhesive pattern 104 and secondadhesive applied in regions 102. The two different adhesives couldprovide adhesive function under different conditions. For example, thefirst adhesive may provide greater adherence to the nose when the noseis dry and the second adhesive could provide greater adherence when thenose is wet from perspiration.

In addition, rather than extending the adhesive pattern to theperipheral edge 109 of the NSD, the engaging layer 110 can include acontinuous adhesive border around the perimeter of the NSD. Such aborder can be about 0.5 to 5 cm, typically about 2-3 cm wide.

FIG. 12 illustrates a bottom plan view of another embodiment of an NSD150 having a discontinuous adhesive pattern 101 of the engaging layer110. The releasable liner has been removed. In this embodiment, thediscontinuous adhesive pattern 101 is provided by creating holes 107through the entire thickness of the device. Note that the holes 107preferably do not pass through the lift members 105. In addition toenhancing the ability of the device 150 to adapt to contour changes ofthe external surface of the vestibular wall, it is believed that holes107 provide for passage of perspiration or other moisture from thesurface of the animals nose to the external surface of the device 150.The ability for moisture to pass external to the device further reducesthe chance of the device 150 disengaging from the nose. As discussedearlier, the shape of the holes is not limited to round.

FIG. 13 is an exploded perspective view of the NSD 150 of FIG. 12. Thisembodiment includes a surface layer 103 having an adhesive 120 on theunderside 121 of the surface layer 103 for adhering the surface layer103 to the top side 123 of the lift members 105. One suitable materialfor the lift members 105 is 1400A MYLAR® (ie 1400 gauge MYLAR® which isabout 350 micron or 14 mils) available from DuPont, Wilmington, Del. Apresently preferred surface material 103 is No. 9906T non-woven medicaltape available from 3M Co., St. Paul, Minn. The engaging layer 110 canbe applied as a liquid adhesive to the underside 121, 124 of the surfacelayer 103 and lift members 105, respectively. Alternatively the engaginglayer can be applied to the underside 121, 124 of the surface layer 103and lift members 105, respectively, as a double sided medical tape ortransfer adhesive. In one embodiment, two layers of No. 1524 transferadhesive, available from 3M Co., St. Paul, Minn., provide the adhesivefor for the engaging layer 110.

An NSD as disclosed herein provides support for the nasal passages of ananimal. The support provides for increased airflow at rest and duringexercise. The air flow facilitating affects of an NSD can be determinedby various methods including measurement of air flow rates, drivingpressure for flow and impedance to air flow. Air flow rates can bemeasured by attaching a pneumotachograph to a face mask worn by anexercising horse. Driving pressure for flow can be measured by passing acatheter via the nares to the pharynx. From the pressure and flows,impedance to air flow can be calculated. Flow volume loops maydemonstrate reduction of dynamic collapse of the nasal passages. It isbelieved that some embodiments of an NSD as described herein willprovide at least about 5-10% reduction in inspiratory impedance, in someembodiments at least about 15-25%, and in some embodiments over a 25%reduction. During preliminary studies, one horse showed over 40%reduction in inspiratory impedance when wearing an NSD of the invention.A detailed description of methods useful for measuring air flow affectsof an NSD are described in Lumsden et al., “Use of Flow-Volume Loops toEvaluate Upper Airway Obstruction in Exercising Standardbreds,” AJVR,54(5):766-775 (May 19, 1993).

In a performance horse, an NSD can be particularly beneficial forreducing the the chance of exercise induced respiratory conditions. Forexample, the inventors foresee use of an NSD to reduce the chance ofexercise induced pulmonary hemorrhage (EIPH) or “bleeders”. The abilityto decrease the incidence of this condition without the use ofpharmacological agents will provide a major benefit to the horseindustry. In addition, an NSD may also facilitate air flow in horsesafflicted with partial or full recurrent laryngeal nerve dysfunction(“roarers”) or dorsal displacement of the soft palate. The device hasbeen shown to reduce the noise associated with recurrent laryngeal nervedysfunction in some horses.

It will be apparent to one of ordinary skill in the art that manychanges and modifications can be made in the invention without departingfrom the spirit or scope of the appended claims.

1. A nasal support device for supporting a first and second lateralvestibular wall of a nose of a domestic animal, said device comprising:a support layer positioned to provide structural support to said firstand second lateral vestibular wall; and an engaging layer for securingsaid device to said nose of said domestic animal; said nasal supportdevice including: a first side piece for engaging said first lateralvestibular wall, said first side piece having a rostral end, a caudalend and a first rostral-poll dimension; a second side piece for engagingsaid second lateral vestibular wall, said second side piece having arostral end, a caudal end and a second rostral-poll dimension; a midlineregion including an intersection of said first and second side pieces,said midline region having a rostral end, a caudal end and a midlineregion rostral-poll dimension that is at least as great as a selectedone of said first rostral-poll dimension and said second rostral polldimension. 2-21. (canceled)